Rheumatoid Arthritis Clinical Trial
Official title:
The Effect of Puerarin Injection on Carotid Intima-Media Thickness in Patients With Rheumatoid Arthritis, a Controlled and Randomized Trial
Verified date | January 2018 |
Source | Chengdu PLA General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to access the effect (week 12/week 24) of puerarin injection on carotid intima-media thickness (CIMT) in rheumatoid arthritis (RA) patients despite routine anti-rheumatic treatment.
Status | Completed |
Enrollment | 119 |
Est. completion date | November 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - patients with a definite diagnose of rheumatoid arthritis(RA) were included if they met the classification criteria for RA established by the American Rheumatism Association (ACR) and European League Against Rheumatism (EULAR) in 2010 - aged from 18 to 75 years - without conflict to the written, informed consent signed prior to the enrollment - no severe hepatic or renal disorders - no known carotid artery stenosis - no coagulation disorders - no hypertension Exclusion Criteria: - being in pregnancy, lactation period or under a pregnancy plan - being allergic to the test drug - not compatible for the trial medication - without full legal capacity |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chengdu PLA General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Kidney function | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks | at 0 week, 12 weeks, 24 weeks | |
Other | Liver function | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks | at 0 week, 12 weeks, 24 weeks | |
Other | blood cell count | from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 weeks | at 0 week, 12 weeks, 24 weeks | |
Primary | Changes from baseline in Carotid intima-media thickness at 24 weeks | Carotid intima-media thickness (CIMT) was using a high-resolution B-mode ultrasound machine (iU22 xMATRIX, Philips, Germany). CIMT was measured twice by a single experienced operator using an 10-MHz linear vascular probe. Patients were let resting in a relaxed supine position, with the head turned gently to the contralateral side when the electrocardiogram was recorded. The imaging system (QLab 6.0, Philips, Germany) was applied to measure the CIMT signals from the proximal internal carotid artery (the arterial segment 10 mm distal to the carotid bifurcation), the carotid bulb and the distal common carotid artery (the arterial segment 10 mm proximal to the carotid bulb). The mean CIMT was calculated from the value of five arterial segments. All the measurement and analysis procedures were performed by a single ultra sonographer and a single reader, who were blinded to patient profiles and group assignment. | At 0 week, 12 weeks, 24 weeks | |
Secondary | low-density lipoprotein cholesterol (LDL-C) | at 0 week, 12 weeks, 24 weeks | ||
Secondary | erythrocyte sedimentation rate (ESR) | at 0 week, 12 weeks, 24 weeks | ||
Secondary | C reactive protein (CRP) | at 0 week, 12 weeks, 24 weeks | ||
Secondary | Total cholesterol (TC) | at 0 week, 12 weeks, 24 weeks | ||
Secondary | triglycerides (TGs) | at 0 week, 12 weeks, 24 weeks | ||
Secondary | tumor necrosis factor (TNFa) | at 0 week,12 weeks, 24 weeks | ||
Secondary | interleukin-8 (IL-8) | at 0 week,12 weeks, 24 weeks | ||
Secondary | interleukin-1 (IL-1) | at 0 week,12 weeks, 24 weeks | ||
Secondary | interleukin-6 (IL-6) | at 0 week,12 weeks, 24 weeks | ||
Secondary | disease activity score in 28 joints (DAS28) | at 0 week,12 weeks, 24 weeks | ||
Secondary | homeostasis model assessment (HOMA-IR) | at 0 week,12 weeks, 24 weeks |
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